ADDE considers the agreement on the EU medical device regulation a good compromise. With the new rules, the European level of safety in medicine and dentistry will be raised to a higher standard. However, the regulation could jeopardise existing relationships between producers and distributors, if manufacturers are not able to meet the required quality and safety standards. Dental dealers would then be forced to work with other producers, which could have an impact on pricing and products.
The agreed regulations are expected to achieve a twofold aim: ensuring that medical devices and in vitro diagnostic medical devices are safe, while allowing patients to benefit from innovative health care solutions in a timely manner.
The main elements include the following:
- Tightened rules for the designation of notified bodies and for the monitoring of their activities by relevant national authorities
- Extra provisions on producers’ responsibilities for the follow-up of the quality, performance and safety of devices placed on the market
- Strengthened rules on clinical investigation seeking to increase the availability of reliable clinical data on medical devices
- The requirement for producers and importers of devices to register themselves and their products on a central EU database
- The setting-up of an EU portal where serious incidents and corrective actions by manufacturers will be reported—devices will have a unique identification number to provide for traceability throughout the supply chain to the end-user or patient.
Certain high-risk devices, such as implants, may undergo an additional check by experts before they are placed on the market. Expert panels and laboratories will play a key role in supporting the legislative system, to provide expertise and guidance on clinical aspects to notified bodies, competent authorities and manufacturers. Furthermore, the new EU rules explicitly cover certain devices without a medical purpose, but with similar characteristics to those of medical devices. Examples are fillers and coloured contact lenses for cosmetic purposes.
The next steps
On 15 June 2016, the Council of the European Union’s Permanent Representatives Committee endorsed the agreement reached with the European Parliament. The European Commission stated that it too supported the agreement reached between the two co-legislators. Since the agreement has been confirmed by the European Parliament’s ENVI Committee, the council will approve the agreement at minister level. This is planned for September, once the draft regulations have been translated into all official languages. After their legal-linguistic revision, the new regulations will have to be approved by the council and the European Parliament. They will apply three years after publication as regards medical devices and five years after publication as regards in vitro diagnostic medical devices.
Please have a look at the official website of the European Council for more information.
BRUSSELS, Belgium: After a three-year transition period and a delay of 12 months owing to the SARS-CoV-2 pandemic, new regulations now apply for medical ...
BRUSSELS, Belgium: The European Parliament has voted to implement two new regulations concerning medical devices with the aim of improving safety in ...
BRUSSELS, Belgium: In April, the European Parliament voted to implement a pair of new regulations concerning medical devices. First proposed in 2012 by the ...
LONDON, UK: A new article presents a comprehensive overview of the evolving regulatory landscape for custom-made medical devices in the UK, offering ...
BRUSSELS, Belgium: Europe is struggling with the effects of the SARS-CoV-2 pandemic and the war in Ukraine, and the bloc could not have picked a worse time ...
LONDON, UK: An investigation headed by the International Consortium of Investigative Journalists (ICIJ) has found that patients worldwide have potentially ...
CANBERRA, Australia: The Australian Dental Industry Association (ADIA) has this week reported that small businesses will be hit particularly hard by a new ...
Dear ADDE members and supporters, the first stakeholder meeting in Brussels on 23 February provided a great opportunity for promoting European dentistry and...
CLOSTER, N.J., U.S.: Many dental professionals have recognized the benefits of using cryotherapy for oral pain management and swelling relief in dentistry, ...
SILVER SPRING, Md., U.S.: As dental workflows continue to become increasingly digitally based, so, too, do certain regulatory processes. The U.S. Food and ...
Live webinar
Thu. 18 July 2024
8:00 pm EST (New York)
Live webinar
Tue. 6 August 2024
6:00 pm EST (New York)
Live webinar
Tue. 13 August 2024
7:00 pm EST (New York)
Live webinar
Wed. 21 August 2024
9:00 am EST (New York)
Dr. Jim Lai DMD, MSc(Perio), EdD, FRCD(C)
Live webinar
Wed. 28 August 2024
8:00 pm EST (New York)
Live webinar
Mon. 2 September 2024
5:00 am EST (New York)
Live webinar
Tue. 3 September 2024
11:00 am EST (New York)
To post a reply please login or register